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Services

We provide contract services of drug delivery formulation developments to pharmaceutical/biotech industries. We specialize in a range of formulation and drug delivery technologies for injectables, from conventional liposomes, Stealth (PEGylated) liposomes for drug delivery, slow release liposomes to solubility enhancing systems such as microemulsions and liposomes. We have strong and broad expertise and over years of experience in the drug delivery field and lipid biophysics. Our services include formulation feasility studies, process development and scale-up, formulation characterization, analytical and nonclinical services. Our capacity range from a few mililiters, to hundreds miiliters to tens of liters

 

Formulation Development

 Ø  All types of liposomes and other lipid-based drug delivery systems

 Ø  Specialized in formulation of difficult compounds

 Ø  Formulation of small molecules, peptides/proteins, nucleic acids

 Ø  Solubility enhancement using liposomes and lipid-based systems

 Ø  Controlled/slow drug release systems

 Ø  Pre-formulation, formulation feasibility and prototype development

 Ø  Extrusion, homogenization, microfluidization, sonication and others

 Ø  Process development, scale-up and process optimization (Design-of-Experiments) and sterile grade filterability studies

Formulation Characterization

 Ø  Particle size (Brookhaven 90Plus part of ZetaPALS)

 Ø  Zeta Potential and Mobility (Brookhaven ZetaPALS, qNano)

 Ø  Particle size distribution (qNano, Brookhaven ZetaPALS)

 Ø  Drug encapsulation efficiency (various approaches)

 Ø  Microscope examinations (uniformity, drug crystals, centrifugation)

 Ø  Particle shape, lamellarity and particle Sub-structure (cryo-TEM, FF-EM)

 Ø  Phase transition, enthalpy of lipids and liposomes, protein denaturation temperatures (MicroCal VP-DSC) 

 Ø Polymer glass transition, melting point (Perkin Elmer DSC 7)

 Ø  Lyophylization/Freeze trying (liposomes, peptide/proteins, Virtis Genesis 35EL with stoppering)

 

Analytical Sciences

 Ø  HPLC method development 

 Ø  HPLC measurement of drug potency and degradents

 Ø  Lipid concentration assay

 Ø  Formulation stability (chemical and physical)

 Ø  In vitro drug release assay

 Ø  pH

 Ø  Osmolality (Wescor Vapor Pressure Osmometer 5520)

 Ø  Refractive Index


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